Status:
COMPLETED
First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme and Resolute Integrity in Patients With de Novo Coronary Artery Stenosis
Lead Sponsor:
Sino Medical Sciences Technology Inc.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Prospective, multi-center, randomized 1:1, single blind trial using BuMA Supreme versus Resolute Integrity conducted in approximately 14 interventional cardiology centers in The Netherlands, Belgium, ...
Eligibility Criteria
Inclusion
- The subject is at least 18 years of age.
- Clinical evidence of ischemic heart disease and/or a positive territorial functional study.
- Documented stable angina pectoris (Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia
- The patient has a planned intervention of a single de-novo lesion in one or two separate major epicardial territories (LAD, LCX or RCA).
- Diameter Stenosis≥50 and\<100%.
- The visually estimated target lesion must be able to be covered by a single BuMA Supreme stent or a single Resolute Integrity stent (for available sizes refer to tables 1 and 2, page 20 and 21).
- The target lesion reference diameter must be visually estimated to be ≥2.5 mm and ≤4.5 mm in diameter.
- Written informed consent.
- The patient agrees to the follow-up visits including a 9 month angiographic follow-up.
- Patient must have completed the follow-up phase of any previous study.
Exclusion
- Female of child bearing potential (age \<50 years and last menstruation within the last 12 months). Subjects with age \<50 who underwent tubal ligation, ovariectomy or hysterectomy can be included.
- Evidence of ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure
- Patient suffered from stroke/TIA during the last 6 months.
- LVEF \<30%
- Platelet count \<100,000 cells/mm3 or \>400,000 cells/mm3, a WBC of \<3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
- Known renal insufficiency (e.g. serum creatinine \>2.5mg/dL, or creatinine clearance ≤30 mL/min), or subject on dialysis, or acute kidney failure (as per physician judgment).
- Patient undergoing planned surgery within 6 months with the necessity to stop DAPT.
- Patient requiring oral anticoagulation (Coumadin, Novel Oral Anticoagulant (NOAC))
- History of bleeding diathesis or coagulopathy
- The patient is a recipient of a heart transplant
- Known hypersensitivity or contraindication to aspirin, heparin, antiplatelet medication specified for use in the study, sirolimus, zotarolimus, or cobalt-chromium.
- Other medical illness (e.g. cancer, stroke with neurological deficiency) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy
- The patient is simultaneously participating in another investigational device or drug study
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT02236975
Start Date
April 1 2015
End Date
March 1 2019
Last Update
July 28 2020
Active Locations (12)
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1
Imelda Hospital
Bonheiden, Belgium
2
CHU Chaleroi
Chaleroi, Belgium
3
Oost-limburg Hospital
Genk, Belgium
4
AMC
Amsterdam, Netherlands